NDA 018656

TELIGENT

FDA Drug Application

Application #018656

Application Sponsors

NDA 018656

TELIGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

40MG/ML

0

DOPAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1983-06-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-03-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-03-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1988-08-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1988-08-03
LABELING; Labeling	SUPPL	9	AP	1992-06-02
LABELING; Labeling	SUPPL	10	AP	1996-10-11
LABELING; Labeling	SUPPL	11	AP	2002-07-17

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0

CDER Filings

TELIGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18656
            [companyName] => TELIGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOPAMINE HYDROCHLORIDE","activeIngredients":"DOPAMINE HYDROCHLORIDE","strength":"40MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DOPAMINE HYDROCHLORIDE","submission":"DOPAMINE HYDROCHLORIDE","actionType":"40MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)